Netherlands Limited-Capacity and Legal Representative Consent Requirements

When this pathway is permitted

Dutch law applies a protective "no, unless" approach to research involving people who lack capacity. Inclusion is permitted where the research may directly benefit the participant, or where non-therapeutic research can be carried out only with the relevant group and the risks and burden are minimal compared with standard treatment or the severity and nature of the condition.

The protocol should justify why this population is needed, how capacity will be assessed, who assesses it, whether capacity can fluctuate, and what safeguards reduce burden. The reviewing MREC or CCMO assesses this justification.

Do not use the representative pathway simply because information is complex or the person needs language assistance. Simplify the explanation and provide communication support first.

Required Dutch documents

Information for the participant

Mandatory. Give the person information suited to their capacity. Explain the purpose, procedures, discomfort, possible benefit, risks, voluntary nature and right to object in the simplest form the person can understand.

This may be a shortened or supported Dutch participant sheet. It does not replace the representative document. Record how the person was involved and any wishes or objections.

Information and consent for the representative

Mandatory. Provide a full Dutch information and consent document addressed to the representative. The adult IVO version 1.1 includes a model consent form for a legal representative. It identifies the participant, the representative, their relationship, the trial consent, required data and sample use, optional choices and the researcher's confirmation.

Submit blank authorised documents in CTIS under Subject information and informed consent form. They are not signed at application submission.

Participant's own consent if possible

Conditional. If the person can make the decision with adapted information and support, the person should consent for themselves. A representative does not replace a participant who has capacity for that decision.

Where capacity is uncertain or fluctuating, define the assessment and reassessment process before recruitment begins.

Who can act as representative

Follow the Dutch order described by CCMO. In general, consent is sought from:

1. a court-appointed curator or mentor
2. a person authorised in writing by the participant
3. the spouse, registered partner or other life partner
4. a parent
5. an adult child who can reasonably be contacted
6. an adult sibling who can reasonably be contacted

Confirm identity, role and authority before consent. A relative is not automatically the representative when a person with higher priority exists. Record the basis on which the representative acts.

The representative must decide in the participant's interests, taking account of the person's known wishes and values. The representative is not enrolled as the trial participant and should not be asked to waive the participant's rights.

Participant involvement and objection

Mandatory. Involve the participant as far as possible. Information should match the person's ability, preferred communication method and current condition.

Respect an explicit wish not to participate or to stop. Objection can be verbal or behavioural. The protocol should explain how investigators recognise and document it, especially for people who cannot communicate conventionally.

A representative's signature does not authorise restraint or the disregard of resistance. Study procedures should stop when the participant objects, apart from any immediate safety step needed to protect the person.

Consent choices and signatures

The representative form should separate:

• consent to trial participation
• data and sample use required for the trial
• access to relevant medical information
• optional future use of data
• optional future use of remaining bodily material
• optional future contact, genetic work or other secondary activities

Optional refusal must not affect the person's trial eligibility or care. The representative should not give broader permission than the participant could have been asked to give.

At consent, the representative signs and dates the form and records the relationship to the participant. The researcher or authorised interviewer signs and dates it. Give the representative the full Dutch information sheet and a signed copy. Document the participant information process separately.

Re-consent when capacity changes

Mandatory. If the participant gains or regains capacity, inform the person and obtain their own consent for continued participation without undue delay. Do this before further trial procedures where practicable and without interrupting necessary clinical care.

If the participant declines, stop trial participation and further research collection. Explain how data and samples already lawfully collected will be handled under the authorised documents and applicable law.

If capacity later becomes impaired again, follow the protocol's approved representative process. A prior competent decision and any advance objection must be respected.

Temporary incapacity and emergencies

Temporary incapacity alone does not permit enrollment without prior consent. If the trial is not an authorised emergency trial, wait for valid participant or representative consent.

For an authorised emergency trial, Article 35 of the Clinical Trials Regulation and the Dutch deferred-consent memorandum apply. Consent must then be sought from the participant or representative as soon as possible. See the Netherlands emergency enrollment consent guide.

Data protection and medical records

Explain what data is collected from the participant and from medical records, who can access it, coding, storage, transfers and withdrawal. The representative consents on behalf of the participant for the authorised trial use. Optional secondary use requires its own choice.

If information about the representative is stored, explain why and for how long. Collect only what is needed to document authority and consent.

The Netherlands secondary-use consent guide explains separate data and sample choices.

Final checks

• The protocol justifies inclusion under the protective Dutch and EU conditions.
• Capacity is assessed for this decision and not inferred from diagnosis.
• The participant receives understandable Dutch information.
• The representative receives the full Dutch information and consent form.
• The correct representative order and authority are documented.
• Participant objection and withdrawal are operationally respected.
• Optional choices are separate from trial participation.
• Signatures identify the representative, relationship and researcher.
• Reassessment and participant re-consent are planned if capacity changes.
• Emergency enrollment is not used outside an authorised Article 35 pathway.

Return to the Netherlands English CTIS hub for the complete guide series.